A Randomized, Double-blind, Parallel Group, Multicenter Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of SAIT101 versus MabThera® versus Rituxan® in Patients with Rheumatoid Arthritis (RA).

Archigen Biotech Limited0 个研究点目标入组 282 人开始时间: 2016年7月15日最近更新: 2018年11月26日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 282

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Male or female outpatient, between 18 and 80 years of age at Screening
•2. Severe RA defined as:
•- Diagnosis of RA according to the revised (1987) ACR criteria for the classification of RA for at least 3 months prior to screening visit.
•- And =6 swollen joints and =6 tender/painful joints (from the 66/68 joint count system)
•- And C-reactive protein (CRP) =1.0 mg/dL or an ESR =28 mm/hour at Screening
•- And positive RF (=20 units/mL) or anti-CCP antibodies (=10 units/mL) at Screening
•3. Patients with severe RA who have had an inadequate response to at least 3 months’ treatment (according to the approved treatment and dosage) or intolerance (at Investigator's discretion and/or experience of intolerable AE or toxicity such as infusion related reaction, hypersensitivity, anaphylaxis or severe toxicity) to anti-TNF therapy (experience of severe AE or toxicity).
•4. Current treatment for RA on an outpatient basis:
•- Receiving MTX 7.5 - 25mg/week (oral or parenteral) for at least 12 weeks, including the last 4 weeks prior to Day 1 at a stable dose, via the same route of administration, dose, and formulation. Patients receiving a lower dose of MTX (<10 mg/week), stable for 4 weeks prior to Day 1, should be doing so as a result of a documented evidence of intolerance to higher doses of MTX.
•- Leflunomide must be withdrawn at least 12 weeks prior to Day 1 or a minimum of 4 weeks prior to Day 1 if after 11 days of standard cholestyramine washout.
•- All DMARDs different from MTX and leflunomide must be withdrawn at least 4 ~ 8 weeks prior to Day 1.
•- If receiving current treatment with oral corticosteroids, the dose must not exceed 10 mg/day prednisone or equivalent. During the 4 weeks prior to Day 1 the dose must be stable.
•- The most recent IM/intra-articular steroid injection should be ?6 weeks prior to Day 1.
•- If receiving current treatment with NSAIDs at the time of Screening, the patient must remain on a stable dose for at least 3 weeks prior to Day 1.
•- Patients are willing to receive oral folic or folinic acid (at least 5 mg/week) or equivalent during the entire study (mandatory co-medication for MTX treatment), according to local standards and availability.
•5. Men and women of childbearing potential must use 2 forms of accepted and highly effective methods of contraception during the course of the treatment period and for at least 12 months after the last infusion of study drug. A man or women is of childbearing potential if, in the opinion of the investigator, he or she is biologically capable of having children and is sexually active. Examples of highly effective contraception include:
•- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation 1:
•* intravaginal
•* transdermal
•- progestogen-only hormonal contraception associated with inhibition of ovulation 1:
•* injectable
•* implantable
•- intrauterine device (IUD)
•- intrauterine hormone-releasing system (IUS)
•- bilateral tubal occlusion
•- vasectomised partner
•- sexual abstinence
•The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
•6. Female patients of childbearing potential must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at each applicable visit thereafter. Females w

排除标准

•1 Females who are pregnant, breastfeeding, or planning a pregnancy
•during the Treatment Period of and 12 months after the last infusion of
•study drug.
•2 Class IV as per the Classification of Global Functional Status in Rheumatoid Arthritis (as per ACR 1991 Revised Criteria) or wheelchair/bed-bound.
•3 History of or current inflammatory joint disease other than RA
•4 History of or current systemic autoimmune disorder with the exception of the secondary Sjögren's syndrome.
•5 Primary or secondary immunodeficiency (history of, or currently active), including known history of human immunodeficiency virus (HIV) infection or positive test at screening.

研究者

发起方

Archigen Biotech Limited

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